Staff Validation Engineer

Cork - Ireland

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Onsite

Contract role with full Stryker benefits.

Member of the Global GQO-QA Validation team as Staff Validation Engineer. Support validation projects and initiatives as per business and guiding multifunctional engineering teams to effectively establish and meet the validation and process development corporate requirements. Responsible for local validation teams in terms of technical expertise and definition of best practices. High visibility and high-risk decision-making role.

This is an individual contributor role that requires the use of judgment in applying professional expertise and one is expected to work independently with minimal supervision.

Who we want:

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas data and insights to drive continuous improvement in functions.
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify standardize and automate.
Goal-oriented developers. Keeping the customer and requirements squarely in focus people who deliver safe and robust solutions.

What you will do:

Will work within the QA Global Validation Team responsible for validation-related activities including but not limited to the following:
- Having knowledge of and ability to provide Interpretation and Guidance on Regulations Corporate Divisional and Site Local procedures as they relate to validation activities.
- Participating within the Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
- Participating in both Corporate and Local Validation Teams to discuss/give feedback and approve revisions to Validation Procedures.
- Representing validation at both internal and external audits.
- Work as part of several cross-functional local and global teams; Visit and work on manufacturing sites per project requirements on a hybrid basis.
- Guides the definition of validation strategies for highly complex validation projects (multiple sites).
- Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
- Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
- Use quality engineering tools statistical methods design development methods process development/control methods and process verification/validation planning to build quality into new and existing products.
- Implement and develop Strykers validation process for newly acquired sites as part of the merge and acquisitions teams
- Working closely with product transfer NPI NPD and AO teams.
- Lead validation continuous improvement projects.
- Implement lean and Six Sigma initiatives to assigned projects and lead teams to apply these methodologies.
- Being the Subject Matter Expert responsible for at least 2 validation specialties and being the primary support for those specialties (e.g. Computer System Validation (CSV) / Qualification of Buildings Facilities and Utilities (BFU) / Measuring System Analysis (MSA) etc.).

What you will need:

Proficiency in Medical Device Validation and QA is needed.
Bachelor of Science Engineering or related subject with 4 years of experience in validation GMPs.
Have a good understanding of engineering and machine tool fundamentals.
Self-starter with demonstrated efficient work methods analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.

Travel Percentage: 20%

Required Experience:

Staff IC

Work Flexibility: OnsiteContract role with full Stryker benefits.Member of the Global GQO-QA Validation team as Staff Validation Engineer. Support validation projects and initiatives as per business and guiding multifunctional engineering teams to effectively establish and meet the validation and p...

Work Flexibility: Onsite

Contract role with full Stryker benefits.

This is an individual contributor role that requires the use of judgment in applying professional expertise and one is expected to work independently with minimal supervision.

Who we want:

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas data and insights to drive continuous improvement in functions.
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify standardize and automate.
Goal-oriented developers. Keeping the customer and requirements squarely in focus people who deliver safe and robust solutions.

What you will do:

Will work within the QA Global Validation Team responsible for validation-related activities including but not limited to the following:
- Having knowledge of and ability to provide Interpretation and Guidance on Regulations Corporate Divisional and Site Local procedures as they relate to validation activities.
- Participating within the Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
- Participating in both Corporate and Local Validation Teams to discuss/give feedback and approve revisions to Validation Procedures.
- Representing validation at both internal and external audits.
- Work as part of several cross-functional local and global teams; Visit and work on manufacturing sites per project requirements on a hybrid basis.
- Guides the definition of validation strategies for highly complex validation projects (multiple sites).
- Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
- Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
- Use quality engineering tools statistical methods design development methods process development/control methods and process verification/validation planning to build quality into new and existing products.
- Implement and develop Strykers validation process for newly acquired sites as part of the merge and acquisitions teams
- Working closely with product transfer NPI NPD and AO teams.
- Lead validation continuous improvement projects.
- Implement lean and Six Sigma initiatives to assigned projects and lead teams to apply these methodologies.
- Being the Subject Matter Expert responsible for at least 2 validation specialties and being the primary support for those specialties (e.g. Computer System Validation (CSV) / Qualification of Buildings Facilities and Utilities (BFU) / Measuring System Analysis (MSA) etc.).

What you will need:

Proficiency in Medical Device Validation and QA is needed.
Bachelor of Science Engineering or related subject with 4 years of experience in validation GMPs.
Have a good understanding of engineering and machine tool fundamentals.
Self-starter with demonstrated efficient work methods analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.

Travel Percentage: 20%

Required Experience:

Staff IC

Key Skills

Python
SOC
Debugging
C/C++
FDA Regulations
Minitab
Technical Writing
GAMP
OS Kernels
Perl
cGMP
Manufacturing

Apply Now

About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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